Certified Clinical Research Professional (CCRP) Exam with complete solution graded A+

When isn't an IND application needed? - IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) How many days after FDA receives IND submission does the IND go into effect? (21 CFR 312.40) - An IND goes into effect 30 days after the FDA receives the submission unless the FDA notifies the Sponsor of a clinical hold When must an IND amendment be submitted? (21 CFR Part 312.31) - -If there are changes to the protocol that affects safety of subjects, scientific quality of the study, or scope of investigation -If a new investigator is added to the study -Information amendments must be submitted for chemistry/microbiology, pharm/toxicology, or clinical OTHER SUBMISSIONS: --IND safety reports --Response to clinical hold --Response to FDA request for information--IRB Annual report What are t he requirements for expanded access? (21 CFR Part 312.300 - Subpart 1) - -Population must have serious or life-threatening disease or condition -No comparable/significant alternate therapy/treatment -Patient cannot obtain drug under another IND or protocol -Potential benefit outweighs risks of treatment -Expanded access won't interfere with completion of studies that could support marketing approval -Must apply to treatment protocols and should be for individual use (1 person) How many days does a Physician or Sponsor have to submit written summary of expanded access to the FDA after use? - 15 days 21 CFR Part 312.34 - Treatment use of an Investigational new drug